CIMZIA PI PDF

PI & CMI Trade Names and Active Ingredients containing certolizumab. 2 Documents cimzia, PI, Certolizumab pegol. Cimzia, CMI, Certolizumab pegol. Cimzia mg solution for injection in pre-filled syringe. 2. QUALITATIVE The recommended starting dose of Cimzia for adult patients is mg (given as 2. An overview of Cimzia and why it is authorised in the EU. Cimzia is a medicine that is used in adults to treat the following diseases: active rheumatoid arthritis (a .

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In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease COPDmore malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.

Severe hypersensitivity reactions have been reported rarely following Cimzia administration. Frequency categories are defined as follows: In both placebo-controlled and open-label follow-up clinical trials for rheumatoid arthritis, cases of lupus-like syndrome were reported uncommonly.

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In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained. Carriers of HBV who require treatment with Cimzia should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs NSAIDs and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.

Injury, poisoning and procedural complications. The results at week 34 are shown in Table 7. Neoplasms benign, malignant and unspecified including cysts and polyps. Cimzia has not been studied in these patient populations. Posology Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis Loading dose The recommended starting dose of Cimzia for adult patients is mg given as 2 subcutaneous injections of mg each at weeks 0, 2 and 4.

Of the patients initially randomised to active treatment in RA-I, completed 52 weeks of placebo-controlled treatment and entered the open-label extension study. In all 3 studies, the PASI 75 response rate was significantly greater for Cimzia compared to placebo starting at Week 4.

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Sign Up Log In Cancel. Musculoskeletal, connective tissue and bone disorders. After patients receive Cimzia, careful attention should be given to interpretation of abnormal coagulation results.

Therefore, early cimzua of any infection, particularly atypical clinical presentations of vimzia serious infection, is critical to minimise delays in diagnosis and initiation of treatment. Among patients initially randomised to Cimzia mg every 2 weeks and Cimzia mg every 4 weeks, As clearance decreases with decreasing body weight, females may generally obtain somewhat higher systemic exposure of certolizumab pegol.

The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.

Patients had a mean time since diagnosis at baseline of 2.

dimzia Fertility Effects on sperm motility measures and a trend of reduced cimzi count in male rodents have been observed with no apparent effect on fertility see section 5. Qualitative and quantitative composition 3. Cimzia may have a minor influence on the ability to drive and use machines. Biotransformation and elimination PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.

In a clinical trial to assess the effect of certolizumab pegol on semen quality parameters, 20 healthy male subjects were randomized to receive a single subcutaneous dose of mg of certolizumab pegol or placebo. Physicians should exercise caution when considering the use of Cimzia in patients with a history of recurring or opportunistic infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.

Cimzia 200 mg solution for injection in pre-filled syringe

Injection site pain was observed in 1. The mean PASI score at cimaia was 20 and ranged from 12 to Malignancies and lymphoproliferative disorders The potential role of TNF-antagonist therapy in the development of malignancies is not known. Cimzia is contraindicated in moderate or severe heart failure see section 4. Therefore, caution should be exercised ip using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking. Cimzia-treated patients reported statistically significant improvements in the Work Productivity Survey compared to placebo.

There is no evidence that Cimzia therapy has an effect on coagulation in vivo. An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate.

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Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy. Date of issue of marketing authorisation valid throughout the European Union.

Cimzia | European Medicines Agency

Product details Name Cimzia. Suitable sites for injection would include the thigh or abdomen.

The pre-filled syringe with needle guard should only be used by healthcare professionals. Therefore, reproductive toxicology studies have been performed with a homologous reagent recognising rat TNF.

The combination of certolizumab pegol and anakinra or abatacept is not recommended see section 4.

The efficacy and safety of 2 dose regimens mg every 2 weeks and mg every 4 weeks of Cimzia versus placebo were assessed in an week, open-label, run-in, and week randomised, double-blind, placebo-controlled clinical trial in ximzia patients with active rheumatoid arthritis diagnosed according to the ACR criteria who had inadequate response to MTX.

Find out more here. Concomitant use with other biologics Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra an interleukin-1 antagonist or abatacept a CD28 modulator and another TNF-antagonist, cimzoa, with no added benefit compared to TNF-antagonist therapy alone. Patients with an inadequate response at Week 16 PASI 50 non-responders were eligible to receive Cimzia mg every 2 weeks until Week 48 in an open label manner.

For women planning pregnancy, continued contraception may be considered for 5 cimzka after the last Cimzia dose ;i to its elimination rate see section 5. Among patients remaining in the study, improvements in all afore-mentioned key efficacy outcomes were maintained through Week in the overall population as well as in the subpopulations.

Appropriate screening tests, e. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.